More Patients Help Drug Companies Pass Valley of Death

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There’s no question the pharmaceutical industry has boatloads of cash. Global sales of prescription drugs total nearly $1 trillion annually, according to IMS Health, a Connecticut-based market research firm. Drug companies spend about $200 billion per year on researching and developing new drugs, according to […]

Navigating the Landscape of Compassionate Use: Siren Interactive Releases New White Paper

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A new white paper was released by Siren Interactive on how to help those who may be considering compassionate use. Requests for compassionate use of investigational drugs have increased dramatically in recent years, according to an FDA study reported in The Wall Street Journal. Rare […]

Head of FDA’s Rare Disease Division Departs, Leaving Agency Looking for New Leader

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The US Food and Drug Administration (FDA) is looking for a new leader for its Rare Diseases Program. In an email to staff on 16 July 2014, John Jenkins, director of the Office of New Drugs (OND), which oversees the rare disease program, said the […]

BioCentury Presents: Right To Try Laws

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TATES’ RIGHTS BY STEVE USDIN, WASHINGTON EDITOR State right-to-try laws, which have been signed by a Democratic governor in Colorado and a Republican in Louisiana, are responses to deep dissatisfaction with the pace of drug development and frustration with the ways biopharma companies have responded […]

Boehringer Ingelheim Announces Nintedanib Expanded Access Program (EAP) for Patients with Idiopathic Pulmonary Fibrosis

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Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the company has initiated an open-label, U.S. multi-center expanded access program (EAP) for its investigational compound nintedanib, for people diagnosed with idiopathic pulmonary fibrosis (IPF) and who meet certain eligibility criteria. Nintedanib is an investigational therapy and has not […]

Registry for Fatal Lung Disease Aims to Speed Improvements in Care

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Duke Clinical Research Institute (DCRI) has launched a patient registry to help researchers and clinicians identify, manage and study people who have a progressive lung disease called idiopathic pulmonary fibrosis. The registry, a joint effort by DCRI and Boehringer Ingelheim Pharmaceuticals, Inc., is the first […]

CureDuchenne Makes Statement Regarding Prosensa Announcement of Regulatory Path Forward for Drisapersen as a Potential Treatment for DMD

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CureDuchenne, a nonprofit that raises awareness and funds research to find a cure for Duchenne muscular dystrophy, issued the following statement today regarding the announcement by Prosensa Holding N.V. (NASDAQ: RNA) that the United States Food and Drug Administration (FDA) has outlined a regulatory path […]